FDA issues class-wide labeling changes for testosterone products

FDA issues labeling changes for all testosterone products following conclusion of ambulatory blood pressure monitoring studies and TRAVERSE trial,

Generic Drugs Program Activities Report – FY 2024 Monthly Performance

This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications.…

Generic Drugs Program Monthly and Quarterly Activities Report

Monthly and quarterly metrics of the FDA Generic Drugs Program.

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions – 03/13/2025

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

Prescription Drug User Fee Amendments

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from…

UPDATED MEETING TIME AND PUBLIC PARTICIPATION INFORMATION: December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee – 12/04/2024

This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak…

Biology and Management of Male‐Bodied Athletes in Elite Female Sports

Graphical representation of the relationships of transgender and XY DSDF as male-bodied athletes along the binary dimensions of biological sex.…

Jobs at CDER Frequently Asked Questions

Frequently Asked Questions about GDUFA Hiring Initiative

POSTPONED – Optimizing Pregnancy Registries – 03/27/2025

Public workshop is part of FDA’s commitment to advance optimal approaches to efficient generation of high-quality human safety data for…